MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for KBL TOWER PURE ENERGY TOWER (2005) manufactured by Kbl Ag.
[72065766]
Claimant alleges sunbed developed smoke after use and caught fire.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3006116732-2017-00002 |
MDR Report Key | 6459742 |
Date Received | 2017-04-05 |
Date of Report | 2017-03-29 |
Date of Event | 2017-02-07 |
Date Mfgr Received | 2017-02-09 |
Device Manufacturer Date | 2006-11-01 |
Date Added to Maude | 2017-04-05 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. THOMAS LAHR |
Manufacturer Street | RINGSTRASSE 24-26 |
Manufacturer City | DERNBACH, 56307 |
Manufacturer Country | GM |
Manufacturer Postal | 56307 |
Manufacturer Phone | 4926899426 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | KBL TOWER PURE ENERGY |
Generic Name | SUNLAMP PRODUCT |
Product Code | LEJ |
Date Received | 2017-04-05 |
Model Number | TOWER PURE ENERGY |
Catalog Number | TOWER (2005) |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
Device Sequence No | 0 |
Device Event Key | 0 |
Manufacturer | KBL AG |
Manufacturer Address | RINGSTRASSE 24-26 DERNBACH, RLP 56307 GM 56307 |
Brand Name | KBL TOWER PURE ENERGY |
Generic Name | SUNLAMP PRODUCT |
Product Code | LEJ |
Date Received | 2017-04-05 |
Model Number | TOWER PURE ENERGY |
Catalog Number | TOWER (2005) |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KBL AG |
Manufacturer Address | RINGSTRASSE 24-26 DERNBACH, 56307 RLP GM RLP |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-04-05 |